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March 01, 2023
In this review, we show a wide range of examples of the expanding use of multivariate analysis (MVA) in pharmaceutical manufacturing and control. MVA is being used to resolve numerous analytical challenges, such as overcoming matrix effects, extracting reliable data from dynamic matrices, and more.
April 01, 2022
It is traceability that shows that the ALCOA criteria does not exist in individual silos, but that they all interact with and are dependent upon each other.
September 01, 2021
Computerized system validation (CSV) has an uninspiring reputation for
being a slow, no-value-added activity that only wastes time and delays the
implementation of new software. Is that an accurate portrayal? And is it a
April 01, 2009
In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.
December 01, 2008
The second part of this column series on traceability matrices looks at some of the practical ways of tracing requirements from the user requirements throughout the life cycle documents.
November 01, 2008
Tracing requirements from a user requirements specification throughout the life cycle is not only a very effective business tool to save time and effort in validation projects but also a regulatory expectation. This first installment of a two-part column series looks at the principles of a traceability matrix.
July 01, 2008
Columnist Bob McDowall discusses the role of a validation master plan (VMP) for summarizing a laboratory's approach to computer validation.
July 01, 2007
Columnist Bob McDowall discusses operating system security patches.
February 01, 2006
Part IV of this four-part series wraps up the discussion of mass calibration, covering the "new generation" attributes that have become apparent as researchers aim to meet the calibration demands of proteomics.